21 U.S. Code § -

The Secretary may by order, at the time of approval or clearance of a device or at any time thereafter, require a manufacturer to conduct postmarket surveillance for any device of the manufacturer that is a class II or class III device—

(i)the failure of which would be reasonably likely to have serious adverse health consequences;

(ii)that is expected to have significant use in pediatric populations; or

The Secretary may order a postmarket surveillance under subparagraph (A) as a condition to approval or clearance of a device described in subparagraph (A)(ii).

(2) Rule of construction

The provisions of paragraph (1) shall have no effect on authorities otherwise provided under the [1] chapter or regulations issued under this chapter.

(b) Surveillance approval

(1) In general

Each manufacturer required to conduct a surveillance of a device shall, within 30 days of receiving an order from the Secretary prescribing that the manufacturer is required under this section to conduct such surveillance, submit, for the approval of the Secretary, a plan for the required surveillance. The Secretary, within 60 days of the receipt of such plan, shall determine if the person designated to conduct the surveillance has appropriate qualifications and experience to undertake such surveillance and if the plan will result in the collection of useful data that can reveal unforeseen adverse events or other information necessary to protect the public health. The manufacturer shall commence surveillance under this section not later than 15 months after the day on which the Secretary issues an order under this section. Except as provided in paragraph (2), the Secretary, in consultation with the manufacturer, may by order require a prospective surveillance period of up to 36 months. Except as provided in paragraph (2), any determination by the Secretary that a longer period is necessary shall be made by mutual agreement between the Secretary and the manufacturer or, if no agreement can be reached, after the completion of a dispute resolution process as described in section
360bbb–1 of this title.

(2) Longer surveillance for pediatric devices

The Secretary may by order require a prospective surveillance period of more than 36 months with respect to a device that is expected to have significant use in pediatric populations if such period of more than 36 months is necessary in order to assess the impact of the device on growth and development, or the effects of growth, development, activity level, or other factors on the safety or efficacy of the device.

(c) Dispute resolution

A manufacturer may request review under section
360bbb–1 of this title of any order or condition requiring postmarket surveillance under this section. During the pendency of such review, the device subject to such a postmarket surveillance order or condition shall not, because of noncompliance with such order or condition, be deemed in violation of section
331(q)(1)(C) of this title, adulterated under section
351(f)(1) of this title, misbranded under section
352(t)(3) of this title, or in violation of, as applicable, section
360(k) of this title or section
360e of this title, unless deemed necessary to protect the public health.

2012—Subsec. (a)(1)(A). Pub. L. 112–144, § 616(1), inserted “, at the time of approval or clearance of a device or at any time thereafter,” after “by order” in introductory provisions.

Subsec. (b)(1). Pub. L. 112–144, § 616(2), inserted “The manufacturer shall commence surveillance under this section not later than 15 months after the day on which the Secretary issues an order under this section.” after “the public health.”

Subsec. (a). Pub. L. 110–85, § 307(2), added subsec. (a) and struck out former subsec. (a). Prior to amendment, text read as follows: “The Secretary may by order require a manufacturer to conduct postmarket surveillance for any device of the manufacturer which is a class II or class III device the failure of which would be reasonably likely to have serious adverse health consequences or which is intended to be—

“(1) implanted in the human body for more than one year, or

“(2) a life sustaining or life supporting device used outside a device user facility.”

1992—Subsec. (b). Pub. L. 102–300substituted “(a)(1)” for “(a)”, inserted comma after “commerce”, and inserted after first sentence “Each manufacturer required to conduct a surveillance of a device under subsection (a)(2) of this section shall, within 30 days after receiving notice that the manufacturer is required to conduct such surveillance, submit, for the approval of the Secretary, a protocol for the required surveillance.”

Effective Date of 1997 Amendment

Pub. L. 105–115, title II, § 212,Nov. 21, 1997, 111 Stat. 2346, provided in part that the amendment made by that section is effective 90 days after Nov. 21, 1997.

“(a) In General.—The Secretary of Health and Human Services (referred to in this section as the ‘Secretary’) shall request the Institute of Medicine to enter into an agreement with the Secretary under which such Institute conducts a study for the purpose of determining whether the system under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] for the postmarket surveillance of medical devices provides adequate safeguards regarding the use of devices in pediatric populations.

“(b) Certain Matters.—The Secretary shall ensure that determinations made in the study under subsection (a) include determinations of—

“(1) whether postmarket surveillance studies of implanted medical devices are of long enough duration to evaluate the impact of growth and development for the number of years that the child will have the implant, and whether the studies are adequate to evaluate how children’s active lifestyles may affect the failure rate and longevity of the implant; and

“(2) whether the postmarket surveillance by the Food and Drug Administration of medical devices used in pediatric populations is sufficient to provide adequate safeguards for such populations, taking into account the Secretary’s monitoring of commitments made at the time of approval of medical devices and the Secretary’s monitoring and use of adverse reaction reports, registries, and other postmarket surveillance activities.

“(c) Report to Congress.—The Secretary shall ensure that, not later than four years after the date of the enactment of this Act [Oct. 26, 2002], a report describing the findings of the study under subsection (a) is submitted to the Congress. The report shall include any recommendations of the Secretary for administrative or legislative changes to the system of postmarket surveillance referred to in such subsection.”

21 CFR Part 26 - MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN...DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY